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Scotland first in the UK to recommend the use of Xolair (omalizumab) to treat chronic spontaneous urticaria

Novartis is delighted that the Scottish Medicines Consortium () has recommended Xolair® omalizumab as an add-on therapy for the treatment of (CSU) in adult and adolescent (12 years and above) patients with an inadequate response to combination therapy with H1-antihistamines, leukotriene receptor antagonists (LTRAs) and H2-antihistamines.[1]

The SMC committee’s positive judgement on omalizumab, which is the first and only add-on therapy to H1-antihistamines to be licensed for the treatment of CSU, follows the European Commission’s approval of the medicine for the treatment of CSU in 2014.[2],[4] Prior to the approval of omalizumab, there had not been a new class of medicine licensed for the treatment of CSU since the 1950s.[5]

For patients who do not respond to H1-antihistamines, LTRAs and H2-antihistamines, omalizumab represents an important treatment option, with the potential to bring relief to the thousands of people living with CSU who are now eligible and who may benefit from treatment.

During three placebo-controlled clinical trials (ASTERIA I, ASTERIA II and GLACIAL) that involved over 1,000 patients not responding to H1-antihistamine treatment, omalizumab 300mg was shown to significantly improve itch and hives, including rapid itch relief, and in many cases completely cleared symptoms.[4],[6],[7] Quality of life was also significantly improved for patients treated with omalizumab 300mg across the Phase III study programme.[4],[6],[7] International experts agree that effective treatment for CSU should ultimately result in patients being symptom-free[5], which is not possible in up-to 50% of cases with the only other licensed therapy, H1-antihistamines, given at licensed doses.[2]

CSU is characterised by red, swollen, itchy and painful ‘wheals’ (also known as ‘hives’) that recur daily, or almost daily for six weeks and can be disabling.[5],[8],[9] Negative physical and emotional effects of CSU include depression and social isolation.[2],[3] CSU has a greater impact on quality of life than leprosy and alopecia.[10]

Professor David Burden, Consultant Dermatologist, Western Infirmary, Glasgow, says: “Chronic spontaneous can be a very distressing condition, which has a huge impact on patients’ physical and psychological wellbeing. For many years treatment options for these patients have been severely limited. Today’s recommendation from the SMC is very welcome and provides people living with CSU and their healthcare professionals an important new treatment option. This news will make a huge difference to the lives of many of my CSU patients in Scotland.”

Maureen Jenkins, Clinical Director, Allergy UK, says: “We hear from people suffering with CSU who are really struggling to cope; it’s a condition which has a significant and often underestimated impact on people’s lives. People living with CSU are often at their wits’ end, longing for relief from their symptoms which can place huge limitations on their everyday lives. We’re delighted that the SMC has recognised the role of omalizumab as an effective treatment for patients who’ve struggled to achieve control over their symptoms using other medicines.”

Novartis is committed to working with the SMC and NHS Scotland to support the swift implementation of the advice that will bring relief to patients who continue to experience the distressing symptoms of CSU.

About Xolair® (omalizumab)

Omalizumab is a targeted therapy that binds to free immunoglobulin E (IgE), which is circulating in the bloodstream. IgE binds to IgE receptors on histamine-releasing cells. Omalizumab suppresses histamine-induced skin reactions, potentially through its reduction of IgE and consequent downstream effects on histamine-release activation mechanisms.

Research is ongoing to fully understand the mechanism of action of omalizumab in CSU, which could lead to deeper understanding of how the disease develops.

In addition to the EU countries, including the UK, omalizumab is currently approved for the treatment of CSU in five countries. Omalizumab is approved for the treatment of moderate-to-severe persistent allergic asthma under the brand-name Xolair® in more than 90 countries, including the US since 2003 and the UK since 2005. In the UK it is approved for the treatment of severe persistent allergic asthma in children (aged six and above), adolescents, and adults.

Source

[1] SMC Advice: Omalizumab as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment. Available: http://www.scottishmedicines.org.uk/ [Available from 12th January 2015]

[2] Maurer M, Weller, K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report. Allergy 66 (2011) 317-330

[3] O’Donnell BF, Lawlor F, Simpson J, Morgan M, Greaves MW. The impact of on the quality of life. British Journal of Dermatology 1997;136:197-201

[4] Kaplan A, Ledford D, Ashby M, et al. Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy. Journal of Allergy and Clinical Immunology. 2013 Jul; 132(1):101-9. doi: 10.1016/j.jaci.2013.05.013

[5] Zuberbier T, Asero R, Bindslev-Jensen C, et al. The EAACI/GA2LEN/EDF/WAO Guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update. Allergy, 2014; DOI: 10.1111/all.12313

[6] Maurer M, Rosén K, Hsieh, HJ, et al. Omalizumab for the Treatment of Chronic Idiopathic or Spontaneous Urticaria. New England Journal of Medicine. 2013;368:924-35

[7] Maurer M. Phase III randomized, double-blind, placebo-controlled study evaluating efficacy and safety of omalizumab in H1 antihistamine-refractory chronic idiopathic/spontaneous urticaria. European Academy of Dermatology and Venereology (EADV) annual meeting 2013. Oral Presentation. 5 October 2013, 11:30 a.m

[8] Sánchez-Borges M. Asero R, Asotegui IJ, et al. Diagnosis and treatment of angioedemia: a worldwide perspective (position paper). World Allergy Organization Journal. 2012; 5:125-147

[9] Wheals of Despair market research amongst 103 patients, November 2013 – January 2014.

[10] Silvares MR, Fortes MR, Miot HA. Quality of life in chronic urticaria: a survey at a public university outpatient clinic, Botucatu (Brazil). Revista da Associação Médica Brasileira 2011;57(5):577-82

Source: Novartis Pharmaceuticals UK Limited